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Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy (CLARIFY)

Primary Purpose

Prostate Cancer, Prostatic Neoplasms

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
64Cu-SAR-bisPSMA
Sponsored by
Clarity Pharmaceuticals Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: At least 18 years of age. Signed informed consent. Untreated, histologically confirmed adenocarcinoma of the prostate. High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL). Patients electing to undergo RP with PLND. Exclusion Criteria: Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components. Patients with known predominant small cell or neuroendocrine PC.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    64Cu-SAR-bisPSMA

    Arm Description

    200MBq 64Cu-SAR-bisPSMA.

    Outcomes

    Primary Outcome Measures

    Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
    Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.

    Secondary Outcome Measures

    Safety and tolerability of 64Cu-SAR-bisPSMA
    Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA
    Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers
    Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic
    PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs
    PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth
    Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer
    Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth
    Ability of 64Cu-SAR-bisPSMA PET to detect primary Prostate Cancer
    Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth
    Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching
    Sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth, without the requirement of subregion (Left or Right) matching between 64Cu-SAR-bisPSMA PET and Standard of Truth

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Clarity Pharmaceuticals Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06056830
    Brief Title
    Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
    Acronym
    CLARIFY
    Official Title
    Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clarity Pharmaceuticals Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer, Prostatic Neoplasms

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    383 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    64Cu-SAR-bisPSMA
    Arm Type
    Experimental
    Arm Description
    200MBq 64Cu-SAR-bisPSMA.
    Intervention Type
    Drug
    Intervention Name(s)
    64Cu-SAR-bisPSMA
    Intervention Description
    All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
    Primary Outcome Measure Information:
    Title
    Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
    Description
    Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.
    Time Frame
    Up to 16 weeks
    Secondary Outcome Measure Information:
    Title
    Safety and tolerability of 64Cu-SAR-bisPSMA
    Description
    Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA
    Time Frame
    Up to 16 weeks
    Title
    Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers
    Description
    Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic
    Time Frame
    Up to 16 weeks
    Title
    PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs
    Description
    PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth
    Time Frame
    Up to 16 weeks
    Title
    Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer
    Description
    Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth
    Time Frame
    Up to 16 weeks
    Title
    Ability of 64Cu-SAR-bisPSMA PET to detect primary Prostate Cancer
    Description
    Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth
    Time Frame
    Up to 16 weeks
    Title
    Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching
    Description
    Sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth, without the requirement of subregion (Left or Right) matching between 64Cu-SAR-bisPSMA PET and Standard of Truth
    Time Frame
    Up to 16 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 18 years of age. Signed informed consent. Untreated, histologically confirmed adenocarcinoma of the prostate. High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL). Patients electing to undergo RP with PLND. Exclusion Criteria: Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components. Patients with known predominant small cell or neuroendocrine PC.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clarity Pharmaceuticals
    Phone
    +61 (0) 2 9209 4037
    Email
    clinicaltrials@claritypharmaceuticals.com

    12. IPD Sharing Statement

    Learn more about this trial

    Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

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